Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Recalled by Butterfly Network, Inc. Due to Distributed without an approved 510(k)
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Butterfly Network, Inc. directly.
Affected Products
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
Quantity: 15,121 host devices
Why Was This Recalled?
Distributed without an approved 510(k)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Butterfly Network, Inc.
Butterfly Network, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report